FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUROLLOYD KF
K Number: K983080
·
Decision Oct 28, 1998
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
626
Applicant Total
7
Review Days
56
Basic Information
- Device Name
- AUROLLOYD KF
- K Number
- K983080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BEGO U.S.A.
- Date Received
- September 2, 1998
- Decision Date
- October 28, 1998
- Product Code
- EJT
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJT), ordered by most recent decision date.
PROMETAL HN86
FDA 510(k)
FDA Class 2
·Dental
BIO 60
FDA 510(k)
FDA Class 2
·Dental
PORTA REFLEX
FDA 510(k)
FDA Class 2
·Dental
PORTA SOLDER 1090 W
FDA 510(k)
FDA Class 2
·Dental
NDX-40 ALLOY
FDA 510(k)
FDA Class 2
·Dental
HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by BEGO U.S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K033279 | GOLD DENTAL CASTING ALLOYS | Jan 15, 2004 | Substantially Equivalent |
| K032136 | WIROBOND C | Sep 4, 2003 | Substantially Equivalent |
| K983082 | BEGOCER G | Oct 28, 1998 | Substantially Equivalent |
| K983078 | BEGOPAL | Oct 23, 1998 | Substantially Equivalent |
| K983077 | BIO PONTOSTAR | Oct 23, 1998 | Substantially Equivalent |
| K983079 | PLATINLLOYD 100 | Oct 23, 1998 | Substantially Equivalent |